The controversial drug Arcoxia is approved in 63 countries, including the U.K. and Mexico, but it failed to pass the approval process in the United States. Created by the pharmaceutical company Merck, the drug is similar in structure and mechanism to rofecoxib, marketed as Vioxx, which was pulled from the market in 2004 due to an unacceptable risk of cardiovascular complications such as heart attack and stroke.
Usage
According to Drugs.com, Arcoxia is used for the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute gout, and chronic musculoskeletal and acute pain. Arcoxia is taken in tablet form once a day in dosages of 60mg to 120mg, depending on the specific condition being treated.
Mechanism
Arcoxia is a cyclooxygenase-2 inhibitor, or COX-2, inhibitor and works by blocking the enzyme COX-2. Since COX-2 is a factor in joint inflammation and pain, blocking it has a pain-relieving effect. Drugs.com explains that Arcoxia is less likely to cause stomach ulcers than nonsteroidal anti-inflammatory drugs, or NSAIDS.
Side Effects
Arcoxia causes side effects in some people who take it. Mild side effects include dizziness, heartburn, nausea and headache. Serious side effects may include an allergic reaction, swelling, heart palpitations, liver or kidney problems and stomach ulcers. Some people experience heart failure as a result of taking Arcoxia, according to Drugs.com.
Contraindications
Some people should not take Arcoxia, including those with coronary heart disease or who are at high risk for developing coronary heart disease, according to Drugs.com. People who have previously had a stroke or heart attack and those with uncontrolled high blood pressure should also avoid this medication. Women who are pregnant or breast-feeding should talk to a doctor before taking Arcoxia.
Approval Status
In April 2007, the Food and Drug Administration, or FDA, officially rejected the application for Arcoxia to be approved in the United States, according to "USA Today." It remains on the market in the 63 other countries in which it is approved, although some epidemiologists such as David Graham of the FDA's Office of Surveillance and Epidemiology want to see the drug banned or recalled in other countries due to the high risk of deadly cardiovascular side effects.
Controversy
Although Arcoxia has been shown to raise the risk of heart attacks and stroke, especially in susceptible individuals, such as those with high blood pressure, some controversy remains regarding the FDA's decision to disapprove it for use in the U.S. According to "Arthritis Today" magazine, many sufferers of arthritis have concerns about the lack of drugs that effectively treat the inflammation and pain associated with their condition, especially after the removal of Vioxx and other COX-2 inhibitors from the market. Some individuals with arthritis argue that they would be willing to take the slight risk of heart disease in exchange for effective relief for their pain, adds the magazine.
